Clinical Study to Validate the Use of a New Point of Care Troponin I Test

Acute Coronary Syndrome Clinical Trial

Official title:

Clinical Study to Validate the Use of a New Point of Care Troponin I Test as an Aid in the Diagnosis of Myocardial Infarction and Prognosis of Subjects Presenting With Symptoms of Acute Coronary Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02620397
• Other study ID #: CP7001_5ACS
• Status: Active, not recruiting
• Phase: N/A
• First received: November 27, 2015
• Last updated: December 14, 2015
• Start date: March 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2015
• Source: Trinity Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)

Description:

This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating Emergency Departments (EDs) with symptoms suggestive of ACS and/or myocardial ischemia. Subjects presenting with symptoms suggestive of ACS will be screened and approached for consent for study enrollment by trained personnel.

After obtaining written informed consent, subjects will have up to 4 blood samples collected for cTnI testing using the Meritas Troponin I test and Meritas point-of-care (POC) Analyzer. Blood draws and testing will occur at 4 intervals over 24 hours.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: November 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. The informed consent must be signed by the subject, or the subject's legal authorized representative.

2. 21 years of age or greater at the time of enrollment

3. Subjects presenting to the ED with any symptoms suggestive of ACS and/or myocardial ischemia, such as but not limited to: subjects currently having chest pain, pressure or a burning sensation across the precordium and epigastrium, pain that radiates to neck, shoulder, jaw, back, upper abdomen and either arm.

Exclusion Criteria:

1. Informed consent form not signed

2. Age <21 years

3. Known pregnancy -

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Florida	Gainesville	Florida
United States	East Carolina University	Greenville	North Carolina
United States	Ben Taub	Houston	Texas
United States	Eastern Idaho Regional Medical Center	Idaho Falls	Idaho
United States	Sunrise Hospital	Las Vegas	Nevada
United States	Kentucky Clinical Trials Laboratories	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	Hennepin County Medical Ctr	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Thomas Jefferson Univeristy	Philadelphia	Pennsylvania
United States	San Francisco General Hospital & Trauma Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Trinity Biotech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance of the Meritas Troponin I test	Clinical performance indicators (Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) and their respective 95 % confidence intervals (CIs) will be calculated for the quantitative determination of cardiac troponin I (cTnI) for use as an aid in the diagnosis of myocardial infarction (MI)	24-hours	No
Secondary	Prognostic capability of sponsor's Meritas Troponin I to predict mortality (all-cause death) and cardiac events (i.e., MI, cardiac death).	Kaplan-Meier survival curves and risk ratios. A multivariate Cox proportional model with known risk factors as covariates in addition to the Troponin test result will be included in the data analysis	1 year	No